TREMFYA (guselkumab) is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn’s disease

A greater number of patients treated with subcutaneous TREMFYA® induction and maintenance achieved clinical and endoscopic remission at 48 weeks in the Phase 3 GRAVITI study versus placebo

TREMFYA® could become the first IL-23 treatment to offer both a subcutaneous and intravenous (IV) induction regimen for patients living with Crohn’s disease (CD), pending FDA approval

PHILADELPHIA, PA (October 28, 2024) – Johnson & Johnson (NYSE: JNJ) today announced results from the Phase 3 GRAVITI study of TREMFYA® (guselkumab), the first and only IL-23 inhibitor, demonstrating robust results in subcutaneous (SC) induction and maintenance therapy. The findings demonstrated significant clinical remission and endoscopic response at 48 weeks in adults with moderately to severely active CD.[1] These results are among the 14 Johnson & Johnson abstracts presented at the American College of Gastroenterology (ACG) 2024, October 25-30.

“The GRAVITI results show that induction treatment with subcutaneous guselkumab is as rapid and robust as we have seen with the IV induction, which could offer a welcome new option for Crohn’s disease treatment,” stated Remo Panaccione, MD, FRCPC, Study Investigator and Professor of Medicine and the Director of the Inflammatory Bowel Disease Unit at the University of Calgary. “The one-year results of this study suggest that SC induction with guselkumab is a promising approach to help people with CD manage their symptoms and achieve meaningful endoscopic improvements.”

GRAVITI SC Induction Week 12 Results:

More than half of patients treated with TREMFYA® (400 mg administered subcutaneously at Weeks 0, 4, and 8) achieved clinical remission versus those in the placebo group (56.1 percent versus 21.4 percent).

Endoscopic response was achieved in 41.3 percent of patients treated with TREMFYA® SC induction therapy versus 21.4 percent in the placebo group. Greater improvements in clinical remission were seen as early as Week 4 with TREMFYA® compared with placebo, demonstrating rapid onset of action.1 GRAVITI SC Induction Week 48 Results:

The rate of clinical remission was more than three times higher with both maintenance doses of TREMFYA® versus placebo (60.0 percent for 100 mg SC every eight weeks (q8w) and 66.1 percent for 200 mg SC every four weeks (q4w) versus 17.1 percent.

Endoscopic response was achieved in 44.3 percent and 51.3 percent of patients in the TREMFYA® 100 mg SC q8w group and 200 mg SC q4w group respectively versus 6.8 percent in the placebo group.

Endoscopic remission was achieved in 30.4 percent and 38.3 percent of patients in the TREMFYA® 100 mg SC q8w group and 200 mg SC q4w group respectively versus 6.0 percent in the placebo group.

“These results show that TREMFYA has the potential to become the only IL-23 inhibitor to offer both SC and IV induction options for Crohn’s disease, and, if approved, will offer choice and flexibility for people living with CD,” stated Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “The convenience of self-administration from the start of treatment is part of our commitment to delivering innovative therapeutic solutions to people with Crohn’s disease.”

The results reinforced the well-established safety profile of TREMFYA.

TREMFYA® received U.S. Food and Drug Administration (FDA) approval in September 2024 for the treatment of adults with moderately to severely active ulcerative colitis (UC) and an application for the treatment of moderately to severely active CD is currently under FDA review. Regulatory applications seeking approval of TREMFYA® for the treatment of adults with moderately to severely active UC and for the treatment of adults with moderately to severely active CD have been submitted in Europe.

ABOUT THE GRAVITI STUDY (NCT05197049)
GRAVITI is a randomized, double-blind, placebo-controlled Phase 3 study to evaluate guselkumab SC induction therapy (400 mg at Weeks 0, 4, and 8) in patients with moderately to severely active Crohn’s disease who experienced an inadequate response or failed to tolerate conventional therapy (i.e., corticosteroids or immunomodulators) or biologic therapy (TNF antagonists or vedolizumab).[2] Patients received guselkumab 400 mg SC q4w (x3) followed by guselkumab 200 mg SC q4w; or guselkumab 400 mg SC q4w (x3) followed by guselkumab 100 mg SC q8w; or placebo. The maintenance doses in GRAVITI (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 GALAXI 2 and GALAXI 3 studies that evaluated the efficacy and safety of IV induction followed by SC maintenance therapy in patients with moderate to severely active Crohn’s disease). Similar to GALAXI, GRAVITI employed a treat-through design, in which patients are randomized to guselkumab at Week 0 and remain on that regimen throughout the study, regardless of clinical response status at the end of induction.2 Participants randomized to placebo were able to receive guselkumab (400 mg SC q4w x3 ➔ 100 mg SC q8w) if rescue criteria were met at Week 16.

ABOUT THE GALAXI PROGRAM (NCT03466411)
GALAXI is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program designed to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies (corticosteroids or immunomodulators) and/or biologics (TNF antagonists or vedolizumab).3 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3).3 Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomized and includes a long-term extension study that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years. Patients received guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8 followed by guselkumab 200 mg subcutaneous maintenance every 4 weeks; or guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8, followed by guselkumab 100 mg subcutaneous maintenance every 8 weeks; or a biologic active control; or placebo. Participants randomized to placebo were able to receive ustekinumab if clinical response was not met at Week 12. Of the 873 individuals pooled across the GALAXI 2 & 3 dataset, 456 (52 percent) had prior history of inadequate response to biologics, 365 (41.8 percent) were biologic-naïve and 52 (6 percent) were biologic experienced without documented inadequate response or intolerance.4 The GALAXI 2 and GALAXI 3 studies were the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus ustekinumab in CD. Data from GALAXI 2 & 3 showed guselkumab was superior to ustekinumab in all pooled endoscopic endpoints.